WO2021187798A1

WO2021187798A1 - Sensing device

Info

Publication number: WO2021187798A1
Application number: PCT/KR2021/002966
Authority: WO
Inventors: 금도희; 김갑영; 홍범선
Original assignee: 엘지이노텍 주식회사
Priority date: 2020-03-17
Filing date: 2021-03-10
Publication date: 2021-09-23
Also published as: CN115297770A; KR20210116007A; US20230113107A1

Abstract

A sensing device according to one embodiment of the present invention comprises: a substrate; a sensor unit that includes an electrode disposed on the substrate, and a connection terminal disposed on the substrate and connected to the electrode; and a stretchable substrate that is connected to the sensor unit and includes a base and wiring disposed on the base, wherein the connection terminal of the sensor unit is connected to the wiring of the stretchable substrate.

Description

sensing device

The present invention relates to a sensing device, and more particularly, to a sensing device including an internal sensor inserted into the body.

With the development of medical technology, medical bioinformation measurement research for monitoring body components and physiological information in real time is being actively conducted. Among them, interest in a sensing device for accurately measuring body components in real time is increasing.

As an example of a sensing device including an in-body sensor, a sensor coated with a bioreactive material reacting with a body component in interstitial fluid is inserted into the body through the skin, and the electrochemical relationship between the body component and the bioreactive material is It may have a structure in which an electrical signal generated due to the action is transmitted to a signal processing unit disposed outside the body.

In this case, as the size of the internal sensor inserted into the human body increases, the contact area with the internal body component increases, and accordingly, the sensing accuracy may be increased. However, as the size of the sensor for the body increases, the feeling of foreign body felt by the user may increase.

In addition, other foreign substances such as proteins flowing in the interstitial fluid as well as body components to be detected may be adsorbed to the internal sensor inserted into the human body. When foreign substances are adsorbed to the sensor, the sensing accuracy may be lowered, and the lifespan of the sensor may be shortened.

Meanwhile, a transmitter that receives, processes, and transmits a signal sensed by the internal sensor may be connected to the internal sensor. In general, the transmitter may include a hard PCB accommodated in a case made of a hard material, and when such a transmitter is attached to the skin, it may cause inconvenience to the user.

An object of the present invention is to provide a sensing device that is accurate, has a long lifespan, and minimizes user inconvenience.

A sensing device according to an embodiment of the present invention includes a substrate, an electrode disposed on the substrate, and a sensor unit disposed on the substrate and including a connection terminal connected to the electrode, and connected to the sensor unit, the base and the base and a stretchable substrate including a wiring disposed on the , and a connection terminal of the sensor unit is connected to a wiring of the stretchable substrate.

The stretchable substrate may include a plurality of stacked wiring layers, and the connection terminal of the sensor unit may be disposed between two wiring layers among the plurality of wiring layers.

The base may be disposed between adjacent wiring layers among the plurality of wiring layers.

Each of the plurality of wiring layers may include a metal layer and a support layer.

At least a portion of the sensor unit may be inserted into the stretchable substrate, and the remaining portion may be drawn out of the stretchable substrate.

The electrode of the sensor unit drawn out of the stretchable substrate may be accommodated in a biodegradable sensor guide, and the electrode of the sensor unit may be injected into the body together with the biodegradable sensor guide.

A portion of the sensor guide may be inserted into the stretchable substrate, and the remaining portion of the sensor guide may be exposed to the outside of the stretchable substrate.

A length of the remaining portion of the sensor guide may be longer than a length of a portion of the sensor guide.

The substrate may be divided into an electrode region in which the electrode is disposed and a connection terminal region in which the connection terminal is disposed, and a width of the connection terminal region may be greater than a width of the electrode region.

The width of the connection terminal region may be greater than one time and less than or equal to five times the width of the electrode region.

The wiring of the stretchable substrate may include a plurality of pads and a connection part connecting the plurality of pads, and a width of the connection terminal may be different from a width of the pad.

It may further include an adhesive portion disposed between the connection terminal and the pad.

A width of the adhesive portion may be between a width of the connection terminal and a width of the pad.

The plurality of wiring layers includes a first wiring layer facing a first side on which the connection terminal of the sensor unit is disposed among both surfaces of the substrate and a second wiring layer facing a second side opposite to the first side, and the first wiring layer It may further include at least one of a signal processing unit and a transmission unit connected to and embedded in the stretchable substrate.

At least one of the signal processing unit and the transmitting unit may include a hard PCB and a chip disposed on the hard PCB.

A signal processing circuit pattern for processing a signal received from the electrode through the connection terminal through the connection terminal may be further disposed on a first surface on which the connection terminal of the sensor unit is disposed among both surfaces of the substrate.

The substrate includes a first surface and a second surface opposite to the first surface, and at least one of a reference electrode, a working electrode, and an auxiliary electrode is disposed on the first surface and the second surface, and the second surface A plurality of connection terminals may be disposed on at least one of the first surface and the second surface.

The substrate includes a first surface and a second surface opposite to the first surface, the first surface facing out, and spirally wound such that the second surface is facing inward, the first surface and at least one of a reference electrode, a working electrode, and an auxiliary electrode may be disposed on the second surface.

The substrate includes a first surface and a second surface opposite to the first surface, the first surface facing out, and spirally wound such that the second surface is facing inward, the first surface At least one reference electrode may be disposed on the surface, and at least one working electrode and at least one auxiliary electrode may be disposed on the second surface.

According to an embodiment of the present invention, it is possible to obtain an in-body sensor having excellent sensing performance and long lifespan by minimizing the influence of foreign substances. According to an embodiment of the present invention, it is possible to obtain a sensing device including an internal sensor capable of minimizing discomfort such as a feeling of a foreign body felt by a user.

1 shows a general continuous glucose monitoring system (CGMS).

FIG. 2 is an example of a cross-sectional view of a sensor in the continuous blood glucose measurement system of FIG. 1 .

3 is a block diagram of a sensing device according to an embodiment of the present invention.

Figure 4 (a) is a cross-sectional view of the sensor unit according to an embodiment of the present invention, Figure 4 (b) is a top view of the sensor unit according to an embodiment of the present invention.

5(a) is a top view of a sensor unit according to another embodiment of the present invention, FIG. 5(b) is a cross-sectional view taken along line A-A' of FIG. 5(a), and FIG. 5(c) is FIG. 5(a) ) is a cross-sectional view of B-B'.

Fig. 6 (a) is a top view of a sensor unit according to another embodiment of the present invention, Fig. 6 (b) is a cross-sectional view taken along line A-A' of Fig. 6 (a), and Fig. 6 (c) is Fig. 6 ( A) is a cross-sectional view of B-B'.

7 (a) is a top view of the sensor unit according to another embodiment of the present invention, Figure 7 (b) is a bottom view of the sensor unit according to another embodiment of the present invention.

8 is a view illustrating a form in which the sensor unit is wound in a spiral shape according to an embodiment of the present invention.

9 is a view showing a form in which the sensor unit is wound in a spiral shape according to another embodiment of the present invention.

10 is a view for explaining the principle of a sensor unit wound in a spiral shape.

11 is a view for explaining a process of manufacturing and injecting a sensor unit into a body according to an embodiment of the present invention.

12 is a top view of a stretchable substrate according to an embodiment of the present invention.

13 is a cross-sectional view of a sensing device according to an embodiment of the present invention.

14 is a cross-sectional view of a sensing device according to another embodiment of the present invention.

15 is a picture of a sensing device according to an embodiment of the present invention.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

However, the technical spirit of the present invention is not limited to some embodiments described, but may be implemented in various different forms, and within the scope of the technical spirit of the present invention, one or more of the components may be selected among the embodiments. It can be combined and substituted for use.

In addition, terms (including technical and scientific terms) used in the embodiments of the present invention may be generally understood by those of ordinary skill in the art to which the present invention pertains, unless specifically defined and described explicitly. It may be interpreted as a meaning, and generally used terms such as terms defined in advance may be interpreted in consideration of the contextual meaning of the related art.

In addition, the terms used in the embodiments of the present invention are for describing the embodiments and are not intended to limit the present invention.

In the present specification, the singular form may also include the plural form unless otherwise specified in the phrase, and when it is described as "at least one (or one or more) of A and (and) B, C", it is combined with A, B, C It may include one or more of all possible combinations.

In addition, in describing the components of the embodiment of the present invention, terms such as first, second, A, B, (a), (b), etc. may be used.

These terms are only used to distinguish the component from other components, and are not limited to the essence, order, or order of the component by the term.

And, when it is described that a component is 'connected', 'coupled' or 'connected' to another component, the component is not only directly connected, coupled or connected to the other component, but also with the component It may also include a case of 'connected', 'coupled' or 'connected' due to another element between the other elements.

In addition, when it is described as being formed or disposed on "above (above) or under (below)" of each component, the top (above) or bottom (below) is one as well as when two components are in direct contact with each other. Also includes a case in which another component as described above is formed or disposed between two components. In addition, when expressed as "upper (upper) or lower (lower)", the meaning of not only an upper direction but also a lower direction based on one component may be included.

1 shows a general continuous glucose monitoring system (CGMS), and FIG. 2 is an example of a cross-sectional view of a sensor in the continuous glucose monitoring system of FIG.

1 and 2 , a typical CGMS 10 includes an in-body sensor 12 and a transmitter 14 . The internal sensor 12 may be in the form of a needle that penetrates the skin and is inserted into the body. The in-body sensor 12 may include an electrode 20 , an enzyme layer 22 disposed on the electrode 20 , and a semi-permeable membrane 24 disposed on the enzyme layer 22 . The CGMS 10 is a system for measuring blood sugar, and the enzyme layer 22 may include glucose oxidase. When the in-body sensor 12 penetrates the skin and is inserted into the body, glucose in the interstitial fluid reacts with glucose oxidase in the enzyme layer 22 to be converted into gluconic acid, and a predetermined charge is released. A predetermined electric charge reacts with the electrode 20 to form a current, and the current flowing through the electrode 20 is transmitted to the transmitter 14 outside the body along a wire (not shown). The transmitter 14 transmits data related to the current transmitted from the electrode 20 to the external terminal 30 , and accordingly, the external terminal 30 may output blood glucose information in the body.

Here, for convenience of explanation, a continuous blood glucose measurement system has been described as an example, but the embodiment of the present invention is not limited thereto. It can be applied to content sensors.

Referring to FIG. 3 , the sensing device 100 includes a sensor unit 110 , a signal processing unit 120 , and a transmission unit 130 , and the transmission unit 130 communicates with an external terminal 200 .

The sensor unit 110 penetrates the skin and is inserted into the body, and senses body components in interstitial fluid. To this end, the sensor unit 110 may use an electrochemical reaction between a predetermined body component and a bioreactive material reacting therewith. That is, when ions and/or electrons are generated by an electrochemical reaction between a predetermined body component and a bioreactive material reacting therewith, the presence or concentration of the predetermined body component may be detected using the resulting current. Since at least a portion of the sensor unit 110 is injected into the body, in this specification, the sensor unit 110 may be referred to as an in-body sensor. A specific structure of the sensor unit 110 will be described later.

Here, the predetermined body component is not limited to blood sugar, and may be various biochemical substances or various biomarkers such as ^{blood sugar, lactic acid, cholesterol, dopamine, coral, Na +} , Ka ^{+ , urea, etc. present in blood or interstitial fluid.} have. In addition, the bioreactive material is a material that reacts with a predetermined body component, and may be an enzyme or the like. For example, when the sensor unit 110 is to sense the sugar level in the body, the bioreactive material may be glucose oxidase.

The sensor unit 110 includes a connection wire and a connection terminal, and the electrode of the sensor unit 110 is connected to the signal processing unit 120 through the connection wire and the connection terminal. Here, the connection wire is connected to the electrode of the sensor unit 110, and the current flowing through the electrode of the sensor unit 110 disposed in the body may be transmitted to the signal processing unit 120 outside the body through the connection wire and the connection terminal. . The signal processing unit 120 calculates information on a predetermined body component by using the amount of current received from the sensor unit 110 . To this end, the signal processing unit 120 may convert the amount of current received from the sensor unit 110 to analog-to-digital, and then calculate the concentration of a predetermined body component.

Then, the signal processing unit 120 transmits the calculated information to the external terminal 200 through the transmission unit 130 . In this case, the transmitter 130 may communicate with the external terminal 200 wirelessly or by wire, and the external terminal 200 may output information received from the transmitter 130 to a display or the like.

Figure 4 (a) is a cross-sectional view of the sensor unit according to an embodiment of the present invention, Figure 4 (b) is a top view of the sensor unit according to an embodiment of the present invention. 5(a) is a top view of a sensor unit according to another embodiment of the present invention, FIG. 5(b) is a cross-sectional view taken along line A-A' of FIG. 5(a), and FIG. 5(c) is FIG. 5(a) ) is a cross-sectional view of B-B'. Fig. 6 (a) is a top view of a sensor unit according to another embodiment of the present invention, Fig. 6 (b) is a cross-sectional view taken along line A-A' of Fig. 6 (a), and Fig. 6 (c) is Fig. 6 ( A) is a cross-sectional view of B-B'. 7 (a) is a top view of the sensor unit according to another embodiment of the present invention, Figure 7 (b) is a bottom view of the sensor unit according to another embodiment of the present invention.

4 to 7 , the sensor unit 110 includes a substrate 300 , a reference electrode 310 , a working electrode 320 , and a counter electrode disposed on the substrate 300 . electrode, 330).

Here, the substrate 300 is flexible and may include a first surface 302 and a second surface 304 opposite to the first surface 302 . Here, the substrate 300 of the sensor unit 110 may be a flexible substrate. The flexible substrate may refer to a flexible substrate that is unbreakable, bendable, rollable, foldable, and bendable. To this end, the substrate 300 may be made of, for example, liquid crystal polymer (LCP), poly ether ether ketone (PEEK), polyimde (PI), or the like. According to this, the substrate 300 is biocompatible and can be flexibly bent according to the flow of interstitial fluid in the body, thereby minimizing the user's sense of foreign body, and thermoforming is possible. In addition, the substrate 300 may have a thickness of 10 to 150 μm, preferably 30 to 130 μm, and more preferably 50 to 100 μm. Accordingly, the shape of the thermoformed substrate 300 may be stably maintained.

The working electrode 320 is an electrode where an electrochemical reaction occurs, and a bioreactive material reacting with a predetermined body component may be coated on the working electrode 320 . Here, the predetermined body component is a component to be sensed by the sensor unit 110, and various biochemical substances such as ^{blood sugar, lactic acid, cholesterol, dopamine, coral, Na +} , Ka ^{+ , urea, etc. present in blood or interstitial fluid, etc.} It may be various biomarkers. In addition, the bioreactive material is a material that reacts with a predetermined body component, and may be an enzyme or the like. Although not shown, a semi-permeable membrane may be further disposed on the bioreactive material. Accordingly, only a predetermined body component to be sensed can be selectively transmitted, and the problem that the bioreactive material coated on the working electrode 320 is separated from the working electrode 320 can be prevented.

The reference electrode 310 is an electrode that forms a potential difference with the working electrode 320 , and the auxiliary electrode 330 is an electrode for measuring a current signal of the working electrode 320 . That is, a voltage may be constantly maintained in the auxiliary electrode 330 , and a current may flow in the operation electrode 320 due to a reaction between a bioreactive material and a predetermined body component. The reference electrode 310 may serve to apply a constant voltage to the auxiliary electrode 330 . The working electrode 320 may be referred to as a working electrode, and the auxiliary electrode 330 may be referred to as a counter electrode.

Meanwhile, referring to FIGS. 4A and 4B , the first surface 302 of the substrate 300 includes at least one reference electrode 310 , at least one working electrode 320 , and at least one An auxiliary electrode 330 may be disposed, and each of the reference electrode 310 , the working electrode 320 , and the auxiliary electrode 330 is connected to the

connection terminals

351 , 352 , 353 through the wires W1 , W2 , and W3 . can be connected Here, the wires W1 , W2 , W3 and the

connection terminals

351 , 352 , 353 may transmit the current flowing through the

electrodes

310 , 320 , 330 of the sensor unit 110 to the signal processing unit 120 outside the body. .

Alternatively, as shown in FIGS. 5A to 5C , a reference electrode 310 and a working electrode 320 are respectively provided on the first surface 302 and the second surface 304 of the substrate 300 . and at least one of the auxiliary electrodes 330 may be disposed. For example, the working electrode 320 and the auxiliary electrode 330 may be disposed on the first surface 302 of the substrate 300 , and the reference electrode 310 may be disposed on the second surface 304 . At this time, the connection terminal 351 connected to the reference electrode 310 is disposed on the first surface 302 of the substrate 300 , and the wire W1 connecting the reference electrode 310 and the connection terminal 351 is It may be disposed on the second surface 304 together with the reference electrode 310 to be connected to the connection terminal 351 through the via hole 306 . Accordingly, since the reference electrode 310 , the operation electrode 320 , and the auxiliary electrode 330 are disposed on both sides of the substrate 300 , the number of electrodes disposed per unit area or unit volume occupied by the sensor unit 110 is reduced. Therefore, it is possible to increase the precision of the measurement.

Alternatively, as shown in FIGS. 6(a) to 6(c) , on one surface of the substrate 300 , the reference electrode 310 , the working electrode 320 , the auxiliary electrode 330 , and the connection terminal 350 . are all disposed, and on the other side some or all of the wires W1, W2, and W3 for connecting the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 and the connection terminal 350 are disposed. can For example, the reference electrode 310 , the working electrode 320 , the auxiliary electrode 330 , and the connection terminal 350 are disposed on the first surface 302 of the substrate 300 , and the wires W2 and W3 are connected to each other. A wire W1 connecting the reference electrode 310 and the connection terminal 351 may be disposed on the second surface 304 of the substrate 300 . According to this, since the

electrodes

310 , 320 , 330 and the wires W1 , W2 , and W3 are dispersedly disposed on both sides of the substrate 300 , the number of electrodes disposed per unit area or unit volume occupied by the sensor unit 110 . , so that the precision of the measurement can be increased.

To this end, at least one via hole 306 is formed in the substrate 300 , the wire W1 connected to the reference electrode 310 through the via hole 306 , the wire W2 connected to the working electrode 320 , and the auxiliary At least one of the wires W3 connected to the electrode 330 may pass through, and each of the reference electrode 310 , the working electrode 320 , and the auxiliary electrode 330 has a connection terminal through the wires W1 , W2 , and W3 . It can be connected to (351, 352, 353). Here, the current flowing through the wires W1 , W2 , and W3 and the

connection terminals

351 , 352 , and 353 may be transmitted to the signal processing unit 120 outside the body. According to this, since the connection terminals 350 are gathered on one side of both surfaces of the substrate 300 and then drawn out of the body, wiring is easy.

Alternatively, as shown in FIGS. 7A to 7B , a plurality of reference electrodes 310 and a plurality of operations are provided on each of the first surface 302 and the second surface 304 of the substrate 300 . An electrode 320 and a plurality of auxiliary electrodes 330 may be disposed. Accordingly, since the plurality of reference electrodes 310 , the plurality of operation electrodes 320 , and the plurality of auxiliary electrodes 330 are disposed on both surfaces of the substrate 300 , per unit area or unit volume occupied by the sensor unit 110 . Since the number of electrodes to be disposed increases, it is possible to increase the accuracy of measurement.

When the connection terminal 350 is disposed on the first surface 302 of the substrate 300 , the wire W1 connected to the

electrodes

310 , 320 , 330 disposed on the second surface 304 of the substrate 300 , W2 and W3 may be connected to the connection terminal 350 disposed on the first surface 302 of the substrate 300 through the via hole 306 .

Although not shown, one set of the reference electrode 310 , the working electrode 320 and the auxiliary electrode 330 is a set of one

connection terminal

351 , 352 , 353 through one set of wires W1 , W2 , and W3 . can be connected to That is, when one sensor unit 110 includes a plurality of sets of reference electrodes 310 , working electrodes 320 , and auxiliary electrodes 330 , each reference electrode 310 , working electrode 320 , and auxiliary electrode A set of

connection terminals

351 , 352 , 353 may be arranged separately for the set 330 . Accordingly, the sensing accuracy may be increased.

Meanwhile, referring to FIG. 4A , a seed layer 340 may be further disposed between the substrate 300 and the reference electrode 310 , the working electrode 320 and the auxiliary electrode 330 , and the seed layer ( 340 may include at least one of titanium (Ti) and nickel (Ni). Accordingly, bonding strength between the substrate 300 and the reference electrode 310 , the working electrode 320 , and the auxiliary electrode 330 may be improved.

Alternatively, before forming the seed layer 340 on the substrate 300 , the substrate 300 may be pretreated. For example, when the surface of the substrate 300 is plasma-treated or the surface of the substrate 300 is coated with a hydrophilic primer, the surface of the substrate 300 is changed to hydrophilicity, so that the surface of the substrate 300 has a seed layer ( 340) is advantageously formed.

Accordingly, adhesion between the substrate 300 , the seed layer 340 , and the

electrodes

310 , 320 , and 330 may be improved.

Meanwhile, each of the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 may include at least one of gold (Au) and platinum (Pt) nanoparticles, and the reference electrode 310 may include silver chloride ( AgCl) may be further included, which may be disposed on the substrate 300 by deposition, sputtering, plating, evaporation, coating, or the like. The particle size of nanoparticles forming the

electrodes

310 , 320 , and 330 may vary according to processing conditions such as deposition, sputtering, plating, evaporation, and coating. According to an embodiment of the present invention, each of the reference electrode 310 , the working electrode 320 , and the auxiliary electrode 330 may include at least one of gold (Au) and platinum (Pt). In this case, each of the reference electrode 310 , the working electrode 320 , and the auxiliary electrode 330 may be formed of a wrinkled metal or a porous metal. According to this, the precision of sensing can be improved. In this case, each of the reference electrode 310 , the working electrode 320 , and the auxiliary electrode 330 may be formed of nanoparticles having a D50 of 5 to 100 nm, preferably 5 to 75 nm, and more preferably 5 to 50 nm. Accordingly, since the surfaces of the

electrodes

310 , 320 , and 330 are smooth, the possibility of adsorption of foreign substances can be reduced. Here, the foreign material means a material other than a body component to be detected, such as proteins, platelets, cells, fibroblasts, immune materials, blood cells, etc. present in blood or interstitial fluid, and the foreign material is on the surface of the

electrodes

310 , 320 , 330 . If it is adsorbed to , the sensing function is deteriorated, and the lifespan of the sensor may be shortened.

Alternatively, in order to reduce the possibility that foreign substances are adsorbed on the

electrodes

310 , 320 , and 330 , the surfaces of the

electrodes

310 , 320 , 330 may be coated with a hydrophobic material. When the surfaces of the

electrodes

310 , 320 , and 330 are coated with a hydrophobic material, foreign substances may not be adsorbed on the surfaces of the

electrodes

310 , 320 , 330 . Here, the hydrophobic material may be a biocompatible hydrophobic material, and the type is not particularly limited.

Meanwhile, according to an embodiment of the present invention, the sensor unit may be implemented in a spiral wound shape.

8 is a view showing a form in which the sensor unit is wound in a spiral shape according to an embodiment of the present invention, and FIG. 9 is a view showing a form in which the sensor unit is wound in a spiral shape according to another embodiment of the present invention.

8 to 9 , the first surface 302 of the substrate 300 may face the outside and the second surface 304 may be wound in a spiral shape toward the inside. Here, the spiral shape may refer to a three-dimensional shape extending while repeatedly rotating with a predetermined curvature in a predetermined direction (eg, the Z direction), and may mean a shape in which the substrate surrounds the outer circumferential surface of the cylinder and continues. The spiral shape may be used interchangeably with a spiral shape, a helical shape, and the like. In this way, when the substrate 300 is wound in a spiral shape, the stress applied to the substrate 300 is dispersed, so it is more flexible than a flat substrate, thereby reducing the effect on the flow of the interstitial fluid, and It can reduce discomfort.

In this case, the substrate 300 may be wound in a spiral shape having a width D of 10 to 1000 μm, preferably 100 to 800 μm, and more preferably 300 to 600 μm. The width D may mean a length in the X-direction perpendicular to the Z-direction in a spiral shape extending in the Z-direction, between the first surface 302 and the other first surface 302 at a predetermined position on the Z-axis. It can mean the maximum distance. When the width D of the substrate 300 satisfies this numerical range, a predetermined body component may freely pass through the empty space formed by the second surface 304 . Capillary action acts on the empty space formed by the second surface 304, and the collection and discharge of the interstitial fluid can occur easily.

In addition, the gap H between the spirals constituting the spiral shape of the substrate 300 may be 1 to 300 μm, preferably 5 to 200 μm, and more preferably 10 to 100 μm. When the gap H between the helixes satisfies such a numerical range, the possibility that foreign substances, such as proteins, penetrate into the empty space formed by the inside of the spiral shape, that is, the second surface 304 is reduced.

Meanwhile, according to an embodiment of the present invention, as shown in FIG. 8 , the reference electrode 310 , the working electrode 320 , and the auxiliary electrode 330 are disposed on the first surface 302 of the substrate 300 . Also, the reference electrode 310 , the working electrode 320 , and the auxiliary electrode 330 may be disposed on the second surface 304 of the substrate 300 . As described above, when the reference electrode 310 , the working electrode 320 , and the auxiliary electrode 330 are disposed on both sides of the substrate 300 , the contact area with a predetermined body component to be sensed is widened, so the accuracy of sensing may increase

Alternatively, according to another embodiment of the present invention, as shown in FIG. 9 , the reference electrode 310 is disposed on the first surface 302 of the substrate 300 , and the working electrode ( 320 and the auxiliary electrode 330 are disposed, the first surface 302 on which the reference electrode 310 is disposed faces outward, and the second surface 304 on which the working electrode 320 and the auxiliary electrode 330 are disposed ) can be wound in a spiral shape to face the inside. As shown in FIG. 10 , the substrate 300 has a width D of 10 to 1000 μm, preferably 100 to 800 μm, more preferably 300 to 600 μm, and the interhelical gap H is 1 to 1000 μm. In the case of a spiral shape wound to be 300 μm, preferably 5 to 200 μm, and more preferably 10 to 100 μm, a predetermined value to be sensed is inside the spiral shape, that is, in the empty space formed by the second surface 304 . body components of the body can pass freely, but the possibility of foreign substances penetrating is reduced. According to an embodiment of the present invention, the first surface 302 on which the reference electrode 310, which has less influence on the deterioration of the sensing function, is disposed, faces the outside, and the working electrode 320 and the auxiliary electrode ( If the second surface 304 on which the 330 is disposed is disposed to face the inside, it is possible to improve the accuracy and durability of the sensor.

11 is a view for explaining a process of manufacturing and injecting a sensor unit into a body according to an embodiment of the present invention. Since the sensor unit is injected into the body, it may be referred to as an in-body sensor in the present specification.

In order to manufacture the sensor unit according to the embodiment of the present invention,

electrodes

310 , 320 , and 330 are formed on the substrate 300 . Here, the substrate 300 may be made of liquid crystal polymer (LCP), poly ether ether ketone (PEEK), polyimde (PI), or the like, and as described above, the surface of the substrate is plasma-treated or coated with a hydrophilic primer to pre-treat. After that, the seed layer may be raised to form an electrode. As described above, the

electrodes

310 , 320 , and 330 may be formed by depositing at least one nanoparticle of gold (Au) and platinum (Pt), sputtering, plating, evaporation, coating, or the like. The pretreatment of the surface of the substrate 300 , the formation of the seed layer, and the formation of electrodes may all be performed on both surfaces of the substrate.

Next, the substrate on which the

electrodes

310 , 320 , and 330 are formed is subjected to thermo-forming. Accordingly, the substrate on which the electrode is formed may be wound in a spiral shape.

Next, the electrode is coated with an enzyme. To this end, dip casting a substrate on which an electrode wound in a spiral shape is formed into an enzyme solution, spraying an enzyme solution onto the electrode, or spreading and fixing a substrate on which an electrode is formed, and then drop casting to an enzyme solution. can do. In this way, when the substrate on which the electrode is formed is thermoformed and then the electrode is coated with an enzyme, the problem that the enzyme is denatured by heat can be prevented.

Next, the enzyme-coated sensor is inserted into the sensor guide.

Referring to FIG. 11( a ), the sensor guide 400 has a needle shape with a pointed end, and an empty space may be formed in the interior 410 . Although not shown, the end of the sensor guide 400 may be open. The sensor unit is inserted into the sensor guide 400 formed according to the above-described method. At this time, the sensor is thermoformed and wound in a spiral shape, but may be inserted into the sensor guide 400 in an unfolded planar shape.

As shown in FIG. 11B , the sensor spread out in a planar shape is surrounded by the sensor guide 400 , and is injected into the body together with the sensor guide 400 .

Thereafter, when the sensor guide 400 is independently drawn out from the body, the sensor is separated from the sensor guide 400 and may be wound back into a thermoformed shape.

Alternatively, the sensor guide 400 may be made of a biodegradable material. Here, the biodegradable material may be a biodegradable polymer, and the biodegradable polymer may be, for example, a polylactide (PLA) or polyglycolic acid (PGA)-based polymer.

Accordingly, after the sensor is injected into the body together with the sensor guide 400 , if the sensor guide 400 is biodegraded in the body, the sensor may be wound back into a thermoformed shape.

As described above, since the substrate 300 according to the embodiment of the present invention is made of liquid crystal polymer (LCP), poly ether ether ketone (PEEK), polyimde (PI), etc., it can be formed into a spiral shape by heat. , after being inserted into the sensor guide 400 in a state in which it is unfolded by a physical force and injected into the body, it can be separated from the sensor guide 400 or restored to a spiral shape when the sensor guide 400 is disassembled.

According to this, it is easy to inject the sensor twisted in a spiral shape into the body without causing inconvenience to the user or damage to the sensor.

Meanwhile, as described above, the current of the in-body sensor, that is, the sensor unit 110 may be transmitted to the signal processing unit 130 outside the body through the connection unit 120 , and the signal processing unit 130 is the sensor unit 110 . Information on a predetermined body component is calculated by using the amount of current received through the connection unit 120 from the controller, and the calculated information is transmitted to the external terminal 200 through the transmission unit 140 . The transmitter 14 of FIG. 1 includes a part of the connection unit 120 , the signal processing unit 130 , and the transmission unit 140 , and may be attached outside the body, generally on the user's skin.

In an embodiment of the present invention, the transmitter 14 of FIG. 1 is implemented as a stretchable substrate. When the transmitter 14 is implemented as a stretchable substrate, it can be directly attached to the skin, and since it is stretchable, it is possible to minimize the feeling of foreign body or discomfort felt by the user.

Referring to FIG. 12 , the stretchable substrate 600 includes a base 610 and a wiring 620 disposed on the base 610 .

The wiring 620 includes a first pad 622 and a second pad 624 , and a connector 626 connecting the first pad 622 and the second pad 624 .

Here, the base 610 is unbreakable, bendable, rollable, foldable, and flexible in addition to being flexible. It may have more stretchable properties. . Accordingly, the base 610 may be implemented as a curved surface, may be stretched in at least one direction by an external force, and may be restored to an original state when the external force is removed. Accordingly, the base 610 may be a stretchable base. To this end, the base 610 may include a polymer resin having a predetermined elasticity. For example, the base 610 may include at least one of polyurethane (PU) and polydimethylsiloxane (PDMS). According to this, the base 610 may be elastically stretched according to an external force.

Meanwhile, the first pad 622 and the second pad 624 are disposed on the base 610 , and the first pad 622 and the second pad 624 are made of the same material as the connection part 626 , or the connection part Although different from (626), it may be made of a material having conductivity. A semiconductor device is disposed on the first pad 622 and the second pad 624 and may be connected to the semiconductor device. Alternatively, the first pad 622 and the second pad 624 may be electrically connected to the component elements of the base 610 or may be connected to an external power source. In this case, the first pad 622 and the second pad 624 may be bent or stretched together with the bending or stretching of the base 610 .

The first pad 622 , the second pad 624 , and the connection part 626 may include a support layer and a metal layer disposed on the support layer. The metal layer may include at least one of Au, Cu, Pt, and Ag, and the support layer may include at least one of liquid crystal polymer (LCP), poly ether ether ketone (PEEK), and polyimde (PI). have. In this case, the support layer may be disposed to contact the base 610 . Accordingly, the adhesive force between the metal layer and the base 610 may be increased.

Meanwhile, the connection part 626 may include a repeated curved pattern. For example, the repeated curved pattern may be a meandering pattern or the like that is meandering. Accordingly, the wiring 620 may be a stretchable wiring, and as shown in FIG. 12(b) , the connection part 626 may also be stretched and contracted along with the stretching of the stretchable substrate 610 .

Alternatively, the connection part 626 may be wound in a spiral shape between the first pad 622 and the second pad 624 . Here, the spiral shape has a predetermined direction, for example, a direction parallel to the plane direction of the base 610 , that is, a direction from the first pad 622 to the second pad 624 , or a second direction from the second pad 624 . 1 may refer to a three-dimensional shape extending while rotating repeatedly with a predetermined curvature in a direction toward the pad 622 . The spiral shape may be used interchangeably with a spiral shape, a helical shape, and the like. At this time, the diameter of the spiral shape is 30 μm to 1 mm, preferably 50 μm to 500 μm, more preferably 100 μm to 300 μm, and the spacing between the spiral spirals is 1 μm to 5 mm, preferably 100 μm to 3 mm. , more preferably 300 μm to 2 mm.

According to this, the wiring 620 can also be bent or stretched without restriction according to the bending or expansion and contraction of the base 610 , and since the degree of integration of the wiring 620 can be increased, the overall size of the stretchable substrate 600 can be miniaturized. can do. In particular, even when the wiring 620 is made of an inorganic material that does not have elasticity, since it may be bent or contracted together with the base 610 due to a spiral shape, the material of the wiring 620 may not be restricted. In addition, even if the wiring 620 is also bent or stretched according to the bending or stretching of the base 610, the actual length of the wiring 620 does not increase, so the resistance change can be minimized and a reliable stretchable substrate can be obtained

According to an embodiment of the present invention, the sensor unit may be connected to a stretchable substrate, and the stretchable substrate may include functions of a signal processing unit and a transmitting unit. According to an embodiment of the present invention, the stretchable substrate included in the sensing device may be stretched by 30 to 50% by an external force.

13 is a cross-sectional view of a sensing device according to an embodiment of the present invention, and FIG. 14 is a cross-sectional view of a sensing device according to another embodiment of the present invention.

13 to 14 , the sensing device 1000 includes a sensor unit and a stretchable substrate connected to the sensor unit. Here, the sensor unit may be the sensor unit described with reference to FIGS. 4 to 11 .

As described above, each stretchable substrate includes a base and a wiring disposed on the base.

For example, each of the stretchable substrates 600-1, 600-2, 600-3, and 600-4 is formed by sequentially applying a metal layer 620-2 and a support layer 620-1 on a PET film, After the metal layer 620-2 and the support layer 620-1 are patterned to form wiring, the wiring is buried in the base 610 and the PET film is peeled off.

The stretchable substrates 600 - 1 , 600 - 2 , 600 - 3 and 600 - 4 manufactured in this way may be stacked in a plurality of layers, and thus may be stacked in a plurality of wiring layers. Wires disposed in different layers may be electrically connected to each other through the via hole 630 formed in the wiring. For example, two layers of wiring included in different stretchable substrates 600 - 1 , 600 - 2 , 600 - 3 and 600 - 4 form the via hole 630 and then conduct the via hole 630 inside. Vias can be formed by filling with a material. The conductive material filling the via hole may be any one material selected from copper (Cu), silver (Ag), tin (Sn), gold (Au), nickel (Ni), and palladium (Pd), electroless plating, Electrolytic plating, screen printing (Screen Printing), sputtering (Sputtering), evaporation (Evaporation), may be filled using any one or a combination of inkjetting and dispensing. A via may be formed in the via hole 630 by forming a seed layer through electroless plating with palladium/nickel/chromium, etc., and then filling a metal material with electrolytic plating, screen printing, or the like. In addition, after laminating multi-layered wiring layers such as first, second, third, and fourth layers, vias connecting the multi-layers may be formed.

Here, the sensing device includes a total of four stretchable substrates 600-1, 600-2, 600-3, and 600-4, and a wiring layer is formed on each stretchable substrate to form a total of four wiring layers. Examples include, but are not limited thereto, and the sensing device may include a stretchable substrate of 2 or more layers in total, preferably 3 or more layers in total, and thus 2 or more layers in total, preferably 3 layers or more in total. It may include more than one wiring layer. According to an embodiment of the present invention, the total thickness of the stretchable substrates 600 - 1 , 600 - 2 , 600 - 3 and 600 - 4 of a total of 4 layers may be 2 mm or less. Accordingly, it is possible to minimize the feeling of foreign body and inconvenience to the user.

13 to 14 as an example, the sensor unit connection terminal 350 is disposed between the wiring layer of the 3-layer stretchable substrate 600-3 and the wiring layer of the 4-layer stretchable substrate 600-4, , at least a portion of the sensor unit is inserted into the stretchable substrates 600-1, 600-2, 600-3, and 600-4, and the remaining portions are the stretchable substrates 600-1, 600-2, and 600-3. , 600-4) can be withdrawn. For example, the

electrodes

310 , 320 , and 330 of the sensor unit penetrate some of the stretchable substrates 600 - 1 , 600 - 2 , and 600 - 3 of the plurality of stretchable substrates to the outside of the stretchable substrate. can be withdrawn.

At this time, one side of both surfaces of the substrate 300 of the sensor unit is disposed to face the 4-layer stretchable substrate 600-4, and the other side is disposed to face the 3-layer stretchable substrate 600-3. can A space spaced apart to dispose the sensor unit between the three-layer stretchable substrate 600 - 3 and the four-layer stretchable substrate 600 - 4 may be filled with silicon (Si) or a silicone resin.

The connection terminal 350 of the sensor unit is disposed between the three-layer stretchable substrate 600-3 and the four-layer stretchable substrate 600-4, and the substrate 300 of the sensor unit to which the wires are wired has a total of three layers. The stretchable substrates 600-1, 600-2, and 600-3 of the stretchable substrates 600-1, 600-2, and 600-3 are drawn out, and the

electrodes

310 and 320 of the sensor unit. , 330 may be inserted into the body while being accommodated in the sensor guide 400 . At this time, a part of the sensor guide 400 is inserted into the stretchable substrates 600-1, 600-2, and 600-3, and the remaining part of the sensor guide 400 is the stretchable substrate 600-1, 600 -2, 600-3) can be exposed to the outside. Accordingly, the

electrodes

310 , 320 , and 330 of the sensor unit may be stably fixed to the stretchable substrates 600 - 1 , 600 - 2 , and 600 - 3 . For example, the length of the sensor guide 400 exposed to the outside of the stretchable substrates 600-1, 600-2, and 600-3 is equal to the length of the stretchable substrates 600-1, 600-2, and 600-3. ) may be longer than the length of the sensor guide 400 inserted into the. Accordingly, the

electrodes

310 , 320 , and 330 of the sensor unit are inserted into the body to increase the contact area with the interstitial fluid.

The connection terminal 350 of the sensor unit is connected to the signal processing unit, and the signal processing unit may signal-process the amount of current received from the

electrodes

310 , 320 , 330 of the sensor unit through the connection terminal 350 . In addition, the signal processing unit is connected to the transmitter, and the signal processed by the signal processing unit may be transmitted to the outside through the transmitter.

To this end, as shown in FIG. 13 , the connection terminal 350 of the sensor unit may be connected to the wirings 620-1 and 620-2 of the stretchable substrate 600-3, and the wirings 620-1, 620-2) may be directly or indirectly connected to the signal processing unit. 4(b), 5(a), 6(a), 7(a) and 7(b), the connection terminal 350 in the substrate 300 of the sensor unit 110 ) may be greater than a width of an electrode region in which the

electrodes

310 , 320 , and 330 are disposed. For example, the width of the connection terminal region in which the connection terminal 350 is disposed in the substrate 300 of the sensor unit 110 is greater than one time the width of the electrode region in which the

electrodes

310, 320, and 330 are disposed, 5 times or less, preferably 1.5 times or more and 4 times or less, more preferably 2 times or more and 3.5 times or less. Accordingly, the connection terminal region can be stably bonded to the stretchable substrate 600 - 3 , and when the sensor unit is injected into the body, separation of the sensor unit can be prevented. At this time, if the width of the connection terminal area in which the connection terminal 350 is disposed in the substrate 300 of the sensor unit exceeds 5 times the width of the electrode area in which the

electrodes

310, 320, and 330 are disposed, it is not stretchable. Since the area of the substrate 300 is too wide, the user may feel a foreign body feeling.

As described above, the wiring 620 may include a plurality of pads and a connection unit connecting the plurality of pads, and the connection terminal 350 of the sensor unit 110 is one of the plurality of wiring layers as shown in FIG. 13 . It may be disposed between two wiring layers. In this case, the connection terminal 350 may be bonded to the pad of the wiring 620-2 through the bonding portion 640, the bonding portion 640 may be a solder ball or a plating layer, and the plating layer may be Au, Ag, Cu, Ni, It may include at least one of Pd and Cr. According to an embodiment of the present invention, the width of the connection terminal 350 may be different from the width of the pad of the wiring 620 - 2 . For example, the width of the adhesive part 640 may be between the width of the connection terminal 350 and the width of the pad of the wiring 620 - 2 .

As shown in FIG. 13 , one of the stretchable substrates 600-1, 600-2, 600-3, and 600-4 stacked in a plurality of layers, for example, a four-layer stretchable substrate 600- 4),

chips

700 and 800 implementing the signal processing unit ( 120 in FIG. 3 ) and the transmitter ( 130 in FIG. 3 ) may be disposed.

That is, the signal processing unit and the transmitting unit may be electrically connected to the wiring 620-2 layer to which the connection terminal 350 is connected.

Here, the signal processing unit 700 and the transmitting unit 800 may be chips implemented as integrated circuits. In this case, the signal processing unit 700 may include a signal processing chip 720 disposed on the hard PCB 710 . Accordingly, even if the stretchable substrate 600 - 4 is bent or stretched by an external force, it is possible to minimize the problem that the signal processing chip 720 is damaged by the bending or stretching of the stretchable substrate 600 - 4 . . Likewise, the transmitter 800 may also be implemented in a form including a transmission chip disposed on a hard PCB.

Alternatively, as shown in FIG. 14 , the signal processing unit 700 may be formed on the substrate 300 of the sensor unit. For example, a circuit pattern for processing a signal for processing a signal received from an electrode through the connection terminal 350 may be further disposed on a surface on which the connection terminal 350 of the sensor unit is disposed among both surfaces of the substrate 300 . That is, the signal processing unit 700 may be implemented in the form of an FPCB on the substrate 300 of the sensor unit. In addition, the signal processing unit 700 may be connected to the transmission unit 800 disposed on the four-layer stretchable substrate 600 - 4 . Accordingly, the signal processing unit 700 and the sensor unit can be easily connected.

Referring to FIG. 15 , the sensing device according to an embodiment of the present invention includes a sensor unit and a stretchable substrate, a connection terminal of the sensor unit is connected to the stretchable substrate, and an electrode of the sensor unit is stretchable together with a sensor guide. It can be seen that it is disposed on the outside of the chiselable substrate.

Although the above has been described with reference to preferred embodiments of the present invention, those skilled in the art can variously modify and change the present invention within the scope without departing from the spirit and scope of the present invention as set forth in the claims below. You will understand that it can be done.

Claims

A sensor unit including a substrate, an electrode disposed on the substrate, and a connection terminal disposed on the substrate and connected to the electrode, and

and a stretchable substrate connected to the sensor unit and including a base and a wiring unit disposed on the base,

The connection terminal of the sensor unit is a sensing device connected to the wiring unit of the stretchable board.
According to claim 1,

The wiring unit includes a plurality of stacked wiring layers,

The connection terminal of the sensor unit is a sensing device disposed between two wiring layers among a plurality of wiring layers.
3. The method of claim 2,

A sensing device in which the base is disposed between adjacent wiring layers among the plurality of wiring layers.
3. The method of claim 2,

Each of the plurality of wiring layers is a sensing device including a metal layer and a support layer.
According to claim 1,

At least a portion of the sensor unit is inserted into the stretchable substrate, and the other portion is withdrawn to the outside of the stretchable substrate.
6. The method of claim 5,

The electrode of the sensor unit is drawn out of the stretchable substrate, accommodated in the biodegradable sensor guide, and injected into the body together with the biodegradable sensor guide.
7. The method of claim 6,

A portion of the biodegradable sensor guide is inserted into the stretchable substrate, and the other portion of the biodegradable sensor guide is exposed to the outside of the stretchable substrate.
According to claim 1,

The substrate is divided into an electrode region in which the electrode is disposed and a connection terminal region in which the connection terminal is disposed, and a width of the connection terminal region is greater than a width of the electrode region.
According to claim 1,

The wiring of the stretchable substrate includes a plurality of pads and a connection part connecting the plurality of pads, and a width of the connection terminal is different from a width of the pad.
10. The method of claim 9,

The sensing device further comprising an adhesive portion disposed between the connection terminal and the pad.
6. The method of claim 5,

The plurality of wiring layers includes a first wiring layer facing a first side on which the connection terminal of the sensor unit is disposed among both surfaces of the substrate and a second wiring layer facing a second side opposite to the first side,

and at least one of a signal processing unit and a transmitting unit connected to the first wiring layer and embedded in the stretchable substrate.
3. The method of claim 2,

A signal processing circuit pattern for processing a signal received from the electrode through the connection terminal is further disposed on a first surface on which the connection terminal of the sensor unit is disposed among both surfaces of the substrate.
3. The method of claim 2,

The substrate includes a first surface and a second surface opposite to the first surface,

At least one of a reference electrode, a working electrode, and an auxiliary electrode is disposed on the first surface and the second surface, and a plurality of connection terminals are disposed on at least one of the first surface and the second surface.
3. The method of claim 2,

The substrate includes a first surface and a second surface opposite to the first surface, the first surface facing outward, and spirally wound such that the second surface faces the inside;

At least one of a reference electrode, a working electrode, and an auxiliary electrode is disposed on the first surface and the second surface.
3. The method of claim 2,

The substrate includes a first surface and a second surface opposite to the first surface, the first surface facing outward, and spirally wound such that the second surface faces the inside;

At least one reference electrode is disposed on the first surface, and at least one working electrode and at least one auxiliary electrode are disposed on the second surface.